CN107708527A - Implanted vital sign sensors - Google Patents
Implanted vital sign sensors Download PDFInfo
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- CN107708527A CN107708527A CN201680032864.9A CN201680032864A CN107708527A CN 107708527 A CN107708527 A CN 107708527A CN 201680032864 A CN201680032864 A CN 201680032864A CN 107708527 A CN107708527 A CN 107708527A
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- Prior art keywords
- sensor assembly
- sensor
- patient
- housing
- wall
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-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
- A61B5/021—Measuring pressure in heart or blood vessels
- A61B5/0215—Measuring pressure in heart or blood vessels by means inserted into the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
- A61B5/0205—Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/07—Endoradiosondes
- A61B5/076—Permanent implantations
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
- A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
- A61B5/686—Permanently implanted devices, e.g. pacemakers, other stimulators, biochips
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
- A61B5/6876—Blood vessel
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6879—Means for maintaining contact with the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/74—Details of notification to user or communication with user or patient ; user input means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/74—Details of notification to user or communication with user or patient ; user input means
- A61B5/746—Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
- A61B2562/02—Details of sensors specially adapted for in-vivo measurements
- A61B2562/0247—Pressure sensors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
- A61B5/0031—Implanted circuitry
Abstract
A kind of implanted vital sign sensors, including：Housing, the housing include Part I, and the Part I limits the first openend, second openend relative with first end and the tube chamber passed through, the size of the Part I and can be substantially fully implanted in patient vessel's wall；And sensor assembly, it is configured to measure artery blood pressure waveform, the sensor assembly has portions of proximal and distal part, and the distal part can be inserted into the tube chamber, and the portions of proximal stretches out from first openend.
Description
Technical field
The present invention relates to a kind of method and system and its method for implantation for implanted vital sign sensors.
Background technology
Can not patient's generally use noninvasive method of out-of-bed activity vital sign is monitored in real time.For example, hand
Patient in art room or ICU wards can wear Blood pressure monitor by cuff on upper arm；The clip pulse blood oxygen instrument on finger；
Adhesive electrode is adhered on skin (close to cardia), for monitor ECG and respiratory rate/breathing pattern；Utilize mouth
Chamber/auditory canal temperature measurement is taken temperature；And the sound by the stethoscope audiometry heart/lung/respiratory tract.These non-wound formula life entities
It is usually cumbersome and heavy to levy sensor.In hospital, handicapped or can not be movable patient usually needs to endure such non-wound formula
Sensor caused inconvenience in itself.
However, the mobility of Non-staying in bed patient and the deficiency of medical care supervision so that the real-time monitoring of vital sign is more chosen
War property.Many patients are not intended to use non-wound formula sensor frequently or measure vital sign in time.In addition, even if patient willingness
Coordinate, but, due to the triviality of this kind equipment in itself, patient often moves or changed to obtain more comfortable position
Device location, so as to cause artifact, read untrue and blood flow occlusion.Moreover, non-wound formula equipment is generally not as implanted passes
Sensor is accurately and stably.
Although having designed the intravascular blood pressure sensor of the formula of being chronically implanted to measure blood pressure in real time, such blood vessel
Interior blood pressure sensor easily blocks blood flow, and is easily caused the formation of endothelial cell damage and thrombus and embolism.It is other
The formula blood pressure sensor of being chronically implanted is located at ductus arteriosus wall external diameter surrounding, and forms automatic mechanical type with sensor diaphragm by flat
Connection.And also some other implanted blood pressure sensors are applied to hospital operating room, cardiac catheterization lab and ICU by the short time
Ward.
The content of the invention
The invention provides a kind of implanted vital sign sensors, it the advantage is that, implanted vital sign sensing
Device includes：Housing, the housing include Part I, and the first openend of Part I restriction, relative with first end second open
Mouth end and the tube chamber passed through, the size of Part I can be substantially fully implanted in patient vessel's wall；And sensor assembly,
It is configured to measure artery blood pressure waveform, the sensor assembly has portions of proximal and distal part, and distal part can be inserted into pipe
Intracavitary, and portions of proximal stretches out from the first openend.
In the other side of the present embodiment, sensor includes pressure sensor, and the pressure sensor, which has, is located at distal side
Partial diaphragm, and when distal part insertion tube intracavitary, the second openend of diaphragm and housing therein is approximately coplanar.
In the other side of the present embodiment, housing further comprises the Part II being substantially orthogonal with Part I；When
When in the Part I implantation ductus arteriosus wall of sensor assembly, the size of Part II can be completely disposed at the outer surface of ductus arteriosus wall
On.
In the other side of the present embodiment, when the distal part insertion tube intracavitary of sensor assembly, sensor assembly
Portions of proximal be configured to be pressed against housing Part II.
At least a portion in the other side of the present embodiment, portions of proximal is configured to seal the first openend, and
And in the distal part insertion tube intracavitary of sensor assembly, there is provided predetermined insertion depth.
In the other side of the present embodiment, the Part I of housing is generally cylindrical, and Part I therein
Length between 100~1500 microns.
In the other side of the present embodiment, the interior artery of thorax (breast) substantially with patient of the length of Part I, chest length
In artery, sustainer, arteria carotis, arteria brachialis, ulnar artery, radial artery, the arteria renalis, Pi arteries, common iliac artery and femoral artery at least
The thickness phase of one in one or vena mammaria interna, jugular vein, vena cave, renal vein, splenic vein, iliac vein and femoral vein
Deng.
In the other side of the present embodiment, sensor further comprises that the sensor assembly for being connected to sensor assembly is protected
Element is held, the sensor assembly holding element is configured to sensor assembly being maintained in Part I.
In the other side of the present embodiment, sensor assembly holding element includes the chain link of multiple interval connections, when remote
When in the partial insertion Part I of side, chain link configures generally about blood vessel surrounding.
In the other side of the present embodiment, the portions of proximal of sensor assembly has the first side and relative with the first side
Second side, and sensor assembly holding element has a first end and the second end, and sensor assembly holding element therein
First end is fixed to the first side of sensor assembly, and the second side of sensor assembly holding element is fixed to the second end.
In the other side of the present embodiment, sensor further comprises that at least one blood oxygen saturation (SpO2) senses
Device, the pulse oximetry sensor have photo-detector, and at least one in multiple interval joining links therein
It is individual that including aperture, and photo-detector therein is configured to be maintained in aperture, and towards vascular wall.
In the other side of the present embodiment, sensor assembly is removably inserted into Part I.
In the other side of the present embodiment, sensor assembly is electrically communicated with charge storage cell, and electricity therein
Charge storing element passes through patient skin induction charging.
In the other side of the present embodiment, sensor assembly is configured to the pressure value of measurement Non-staying in bed patient in real time.
In another embodiment, a kind of method for being implanted into vital sign sensors, including：It is percutaneous to promote vascular puncture member
Part.Vascular wall is pierced through with vascular puncture element, and promotes vascular puncture element to adjacent substrate film and the portion through substrate membranous wall
It is at least one in position, to form a cavity wherein.Housing slides on vascular puncture element, and is positioned in cavity；
Housing is defined to tube chamber therein.Sensor assembly is inserted into housing tube chamber, and the sensor assembly is configured to survey
Measure endovascular blood pressure waveform.
In yet another embodiment, implanted vital sign sensors, including：Elongated and biodegradable housing, should
Housing includes：Part I, the Part I limit the first openend, second openend relative with first end and passed through
Tube chamber, the size of the Part I can be substantially fully implanted in patient vessel's wall；And Part II, the Part II and
A part is substantially orthogonal, and when the distal end insertion ductus arteriosus wall and its basilar memebrane and endothelial cell of Part I are substantially coplanar
During position, it is configured to contour with the outer surface of ductus arteriosus wall；And sensor assembly, it is positively retained in Part I, the sensing
Device module has pressure sensor, is configured to measure arterial blood pressure waveform, the sensor assembly has response intra-arterial blood pressure
The suitable diaphragm of waveform, when sensor assembly is maintained in Part I, the basilar memebrane and endothelium of diaphragm and ductus arteriosus wall are thin
Born of the same parents are substantially coplanar.
Brief description of the drawings
Below in conjunction with the accompanying drawings, by reference to described in detail below, will be easier to of the invention and its appended advantages and features
It is more fully understood, wherein：
Fig. 1 is the positive view of the implantable sensor embodiment of constructed in accordance with the principles；
Fig. 2 is the positive view of the wall of implantable sensor implantable intravascular shown in Fig. 1；
Fig. 3 A are the side views of implantable sensor shown in Fig. 2；
Fig. 3 B are the positive views of implantable sensor shown in Fig. 3 A；
Fig. 4 is the positive view of implantable sensor shown in Fig. 1, and implantable sensor therein, which has, to be kept it in
Flexible support arm or fabric on vascular wall and in vascular wall tissue；With
Fig. 5 is the system view that the exemplary vital sign sensors being implanted into communicate with wrist-watch and tablet personal computer.
Embodiment
" first " and " second " used herein, " ... on " and " ... under ", " preceding " and " rear " and
" ... among ... within and ... around " etc. relational terms be only used for distinguishing an entity or element and another
Entity or element, and not necessarily require or imply any physically or logically relation or order between the entity or element.
Referring now to accompanying drawing, identical reference number refers to identical part in figure；Fig. 1-Fig. 5 is shown according to the application principle
Construction and the exemplary implanted vital sign sensors device and monitoring system generally represented with " 10 ".It is used herein
" vital sign " one word refers to the measurement relevant with the body basic function of sufferer (mankind or animal), includes but is not limited to：The heart
Rate, blood pressure, blood pressure waveform, CBF, respiratory rate, tidal volume, electrocardiogram, body temperature, hemoglobin saturation with oxygen, position, work
Momentum and measurement of correlation.The equipment 10 may include housing 12, and its size substantially can be at least completely maintained in the vascular wall of patient,
Especially in vein or arterial blood tube wall.
Formula life physical sign monitoring device 10 is chronically implanted to monitor one or more of following parameters in real time, from
And according to the limit mode for the individual patient lived in true environment, determine whether parameter occurs significant changes：Heart rate, the heart
Rule, often win output quantity, blood pressure, systemic vascular resistance, CBF, myocardial contractive power, valvular function, heartbeat time interval, exhale
Frequency, respiratory rhythm, tidal volume, blood oxygen saturation, heart sound, lungs sound, upper respiratory tract sound, intestines sound, body temperature, electrocardiogram is inhaled (to lead
Connection 2, V2 and V5), activity, position and ground location.In addition, it is chronically implanted formula life physical sign monitoring device 10 also recordable one
Individual or multiple parameters, are used for following explanations.
For example, housing 12 may be sized to across the interior artery of thorax (breast), lateral thoracic artery, arteria subscapularis, rib
Between in artery, arteria epigastrica superior, arteria carotis, sustainer, the arteria renalis, common iliac artery, femoral artery, arteria brachialis, ulnar artery and radial artery
At least one wall thickness, its wall thickness is about in 100-1500 micrometer ranges.For another example, housing 12 may be sized to cross over chest
In wide internal jugular vein, lateral thoracic vein, jugular vein, vena cave, axillary vein, brachial vein, iliac vein, femoral vein and peripheral vein extremely
Few one wall thickness, its wall thickness is about in 40-1000 micrometer ranges.In addition, housing 12 may be sized to cross over pulmonary artery
Or the wall thickness of pulmonary vein, its wall thickness is about in 40-1000 micrometer ranges.Housing 12 can be by biodegradable biocompatibility material
Material composition, make its can after predetermined time amount degradation in vivo.Or housing 12 can by stainless steel, titanium, composite, ceramics,
Silicones, polytetrafluoroethylene (PTFE) (PTFE), polyethylene (PC), polyvinyl chloride (PVC), epoxy resin or glass etc. will not be sent out with the time
The biocompatible materials composition of raw degraded.Housing 12 can have smooth texture, and coating one or more can promote blood vessel group
Knit the compound of degree of sticking and health.
Housing 12 may include Part I 14, and the size of Part I 14 is substantially across the artery or quiet for being implanted with housing 12
The whole wall thickness of arteries and veins.Part I 14 can be generally cylindrical, and defines tube chamber 16 wherein.For example, work as Part I 14
When inserting arteria thoracica interna, the length and one about 1 square millimeter of surface area of an about 300-600 micron can be limited.At it
During he configures, Part I 14 can limit any size and substantially cross over the hollow structure of arterial wall thickness, and can carry wherein
For tube chamber 16.Part I 14 can further limit a smooth outer surface, make it easy to be placed in ductus arteriosus wall tissue, or
Person can screw-type connection on its outer surface, so as to by rotating Part I 14 make it be fixed in ductus arteriosus wall tissue.The
A part 14 can be adhered in ductus arteriosus wall by adhesive, or may include to be meshed with surrounding tissue grain surface, fall
Hook or fork thorn.Part I 14 further comprises the first openend 18, is configured to thin close to artery (inner membrance) basilar memebrane and endothelium
Born of the same parents are set, and the blood that the first openend 18 is flowed with artery or intravenously is not contacted；It is and relative with the first openend 18
Second openend 20.In an exemplary configuration, when Part I 14 is implanted ductus arteriosus wall, the first openend 18 and blood
The distance between stream is about between 5-200 microns.In another configuration, the first openend 18 and basilar memebrane and endothelial cell are big
Cause coplanar.In another configuration, first end can stretch into 5-200 microns in arterial lumen, be contacted with fluid flow blood.
The Part II 22 of housing 12 is attached to the second end 20.Part II 22 can be set to Part I 14 substantially
It is orthogonal, and can be across at least a portion in ductus arteriosus wall external diameter and contour with it.For example, Part II 22 can substantially be in flat square
Shape or circle, or a flexibility substantially corresponding with ductus arteriosus wall external diameter flexibility can be limited, so as in Part I
14 when being placed in ductus arteriosus wall, Part II 22 is pressed against ductus arteriosus wall external diameter.Part II 22 can further limit flat
Smooth inner surface and circular or spherical outer surface, so that Part II 22 stretches out artery external diameter certain distance.First end 18 and
The distance between the inner surface of two part 22 is predeterminable, so as to which when Part II 22 is pressed against to ductus arteriosus wall, first end 18 can be tight
Adjacent basilar memebrane and endothelial cell are set.Therefore, Part II 22 is configured to play the effect of block, in order to which Part I 14 is inserted
Enter in ductus arteriosus wall to required depth.
Ultrasonic measurement ductus arteriosus wall external diameter, thickness and internal diameter can be used, to determine to be adapted to the housing 12 of length/size, the
A part 14 and Part II 22.Specifically, surgeon can be according to the He of Part I 14 of default choice of the substrates certain height
The Part II 22 of length-specific, to adapt to artery or vein same patient of different sizes, or the different patients that wall thickness is different.
Vital sign sensors module 24 releasably or is permanently inserted into and is placed at least a portion of housing 12.
For example, at least a portion of vital sign sensors module 24 can be inserted into the tube chamber 16 that the second openend 20 enters housing 12.Mould
Block 24 may include sensor housing 26, and sensor housing 26 includes one or more biology sensors, e.g., force snesor or pressure
Sensor, its be configured to measure patient one or more physiological parameters, and these parameters can be changed and with one or
Multiple vital sign measurements are associated.Specifically, sensor assembly 24 may include pressure sensor, is configured to association and sets
Put the deflection measured value and blood pressure measurement (detailed description in following article) of diaphragm therein.Module 24 is slidably received in
In tube chamber 16, so as to keep it in tube chamber 16 and ductus arteriosus wall.In one configuration, module 24 is included with optical fiber 30
Capillary 28, or optical sensing mechanism 30, its distal end have sensor diaphragm 32.
For example, capillary 28 can have optical fiber or the optical sensing mechanism 30 being arranged in capillary 28, the optical sensing
There is rigidity, semi-flexible or flexible membrane 32, one part to be placed in tube chamber 16 for the distal end of mechanism 30, and around close to the
The endarterium cell of one openend 18 is set.
As shown in Figure 1-2, optical fiber 30 extends through housing 26, and is extended out to from artery and be roughly parallel to artery length
Position, but can also extend in any direction.In one embodiment, it is not necessary to which optical fiber 30 is set, and light sensing mechanism can make
For a part for module 24, blood pressure (BP) waveform is measured by measuring the displacement of each beat pulse diaphragm 32.It is dynamic every time
Arteries and veins or venous pulse bounce can cause tissue and the inboard/outboard of diaphragm 32 to move one section of distance directly proportional to pulse wave energy,
And the distance can associate the measurement data of generation BP waveforms.In an exemplary configuration, diaphragm 32 is only by endothelial cell, substrate
Film and/or a small amount of knot hoof tissue coverage.In one configuration, embodiment has the optics being encapsulated in sensor housing 26
And electronic device, and the capillary 28 and diaphragm 32 being encapsulated in tube chamber 16.Once implant, basilar memebrane and endothelial cell
It can be grown since damaged arteries tube wall tissue edge, spread all over the surface of diaphragm 32, to generate a continuous biocompatibility/blood
Liquid biocompatible interface.And covering the very thin cellular layer of the outer surface of diaphragm 32 and/or connective tissue layer can become firm, and not
The measurement data of intravascular blood pressure waveform can be influenceed.
The pressure sensor example that can be included in sensor assembly 24 includes having single or multiple deflectable diaphragms 32
Sensor, diaphragm 32 therein is with Wheatstone bridge, single or multiple piezo-electric crystals or can accurately measure diaphragm 32 and moves
Optical arrangement.Because diaphragm 32 is against inner membrance setting, therefore, module 24 can generate the accurate measurement number of intravascular blood pressure waveform
According to without distorting, compressing or flatten ductus arteriosus wall, arterial lumen, vein tube wall or vein tube chamber.
After implantation, the outer surface of diaphragm 32 can keep cleaning or by protein, carbohydrate, lipid and other compounds
Coating.The outer surface of diaphragm 32 can also be coated by basilar memebrane, other connective tissues and endothelial cell.The outer surface of diaphragm 32 has
Texture or coated with natural or synthetic biomaterial, to strengthen the adhesive force of basilar memebrane and endothelial cell (inner membrance).Coat film
The outer surface of piece 32 can change the physical motion characteristic of diaphragm 32.Coating (not shown) can become after implanting in a few days to several weeks
It must stablize.Therefore, the pressure/force sensor of implantation can keep stable over time, and seldom need with outside BP cufves
Measuring system is recalibrated as calibration benchmark to it.The BP can also include barometer and thermometer (measurement with reference to cuff
Atmospheric pressure and temperature), to strengthen the calibration to the BP sensors of implantation.
In other configurations, sensor diaphragm 32 may be provided at outside ductus arteriosus wall, any depth or exposure in ductus arteriosus wall
In in the arterial lumen of fluid flow blood.For example, pillar (not shown) can be located in fluid flow blood (arterial lumen), its distal end or branch
Post side has diaphragm 32.Intravascular pillar can be in 90 degree (90 degree) or with Wall of Artery to be in random angle with Wall of Artery
The mode of degree (+320 degree -- 320 degree) is inserted.The diaphragm 32 of module 24 may be provided at towards on the pillar side of blood flow with
And any position (0-360 degree) relative to blood flow.Intravascular pillar BP sensor assemblies 24 also can use arm-type BP to join
Examine cuff recalibration.The change of external pressure meter and thermometer measure atmospheric pressure and temperature can be used, to improve the BP of implantation
The calibration accuracy of the output signal of sensor.
Module 24 can further be configured to the blood pressure waveform of measurement patient in real time.The measure heart can be analysed by analysis waveform
Rate, heart rate variability degree, often win output quantity, often win output quantity degree of variation, myocardial contractive power, vascular resistence, contraction and diastolic time
Interval, aorta petal and mitral valve function, CBF and respiratory rate/breathing pattern.For example, sensor assembly 24 may include to locate
Device is managed, is configured to associate physiological measurements parameter and vital sign measurements, vital sign measurements therein can be used
Memory transmits and/or storage.Module 24 can further comprise one or more other vital sign sensors, and it is arranged at
Set or be arranged in the other parts of module 24 in housing 26 or along the other parts of module 24.For example, blood oxygen saturation passes
Sensor, temperature sensor, electrocardiograph (ECG) electrode, sonic transducer and activity sensor can as module 24 a part (such as
Detailed description hereinafter).
Module 24 may include the sensor assembly holding element 34 set around artery or vein surrounding.Sensor assembly is protected
Holding element 34 may include multiple chain links 36, and each chain link 36 may be movably attached to contiguous links 36, with around artery or vein
Characterizing portion girth.Multiple chain links 36 can be connected to sensor housing 26 or Part II 22, so as to entirely around artery or
Vein.The arterial pulse when mobility of chain link 36 can make the blood flow through artery, without shrinking artery or vein, and it can make
Housing 26 keeps contacting with ductus arteriosus wall or wall of vein.Make chain interannular and the mutual holding between sensor assembly and vascular wall
Mechanism can have it is small, in or larger elasticity.The inner surface of each chain link 36 can further limit sky/grain surface more, make it can
Blended with ductus arteriosus wall tissue or wall of vein tissue, so as to make ductus arteriosus wall or wall of vein and chain link during pulsating nature blood flow
36 is substantially simultaneously mobile.Chain link can also have one or more permission vascular wall tissues and the ingrown through hole of vasa vasorum
Or passage.Oximetry sensor (pulse blood oxygen SpO2 instrument) 38 can be integrated into the body of one or more chain links or housing 26
It is interior.For example, in the configuration for being surrounded by 5 chain links 36, the part of SpO2 sensors 38 is attached to one or more chain links
In 36, to generate multiple photo-plethysmographic waveforms and SpO2 measurement data.In one configuration, each chain link 36 has size can
The groove (not shown) of one (e.g., light source and/or detector) in accommodating SpO2 sensor elements, so that intra-arterial blood
Obstruction between flowing and SpO2 sensors 38 exists only in ductus arteriosus wall tissue.The light source and photodetector of pulse blood oxygen instrument can
On the same chain link or different chain links of artery opposite side.Each SpO2 sensors 38 can lead to the processor in housing 28
Letter, for example, by the conductor being arranged in sensor assembly holding element 34, sensor assembly holding element 34 therein makes often
Individual SpO2 sensors 38 are connected with each other, and are connected to processor.Alternatively, other sensors (e.g., ECG sensor or other electricity
Pole) it may be disposed in sensor assembly holding element 34 or set around sensor assembly holding element 34.For example, can be by electrode
The opposite side of sensor assembly holding element 34 is arranged on, to measure electrocardiogram, CBF, blood flow rate, body temperature, the heart/lungs sound, exhale
Inhale frequency and breathing pattern.
Referring now to Fig. 4, in other configurations, sensor housing 26 can be by the softness that is arranged in a part for chain link 36
And flexible support, fabric or mesh 40 are fixed to artery outer wall.These materials can have open structure, to reduce
The scale of construction and it is easy to outer membrane and vasa vasorum ingrowing.For example, sensor housing 26 can use size to surround artery surrounding
The flexible support 40 of setting is made, so that capillary 28 and sensor diaphragm 32 are attached in tube chamber 16.Support, fabric or net
Shape thing 40 can be not biodegradable, so as to be degraded over time, or can also be biodegradable
, so as to be degraded in the given time, leave that module 24 is attached to adventitial tissue and capillary 28 is attached to arterial
Wall tissue.Support, fabric or mesh can limit a diameter bigger than the diameter of module 24 and surround module 24 and support 40.It can enter
One step surgical clip, suture or tissue adhesive, module 24 is fixed to ductus arteriosus wall with reference to support 40 or substitute
Tissue.For example, as shown in Figure 3 B, suture passes through a part for each chain link 36, and is connected directly to module 24.Each chain link
36 can limit one or more through holes or passage, and suture, bandage or support 40 can be easy to housing 26 by through hole or passage
It is fixed to ductus arteriosus wall.
Referring now to Fig. 5, the sensor assembly 24 around right internal mammary artery implantation, implantation upper right wall of the chest skin are shown in figure
The additional sensor module 42a of undertissue and the second additional sensor module 42b of the implantation upper left wall of the chest hypodermis position
Put.Each sensor assembly 24,42a and 42b can be made up of one or more vital sign sensors.For example, hypodermis passes
Sensor module 42a and 42b may include ekg electrode, microphone, GPS sensor, accelerometer and temperature sensor.The sensing of implantation
Device 24,42a and 42b can be communicated by radio frequency telemetry technology with the external controller 44 with display screen.For example, controller can be with
It is smart mobile phone, tablet device or intelligent watch, e.g.,Apple 44 (Fig. 5) or
Deng its application program carried can be with the processor communication with process circuit, and process circuit therein is configured to and is implanted into
Sensor 24,42a and 42b communications, and show metrical information.In one configuration, the wearable built-in radio communication of user is set
Standby intelligent watch, built-in Wireless Telecom Equipment therein can communicate with sensor 24,42a and the 42b of implantation, correlation measurement number
According to display result.Patient and doctor can show and handle sensor real-time recorded data with controller 44, calibration sensor and
Exclude sensor fault.Controller 44 can include barometer, calibrated, accurate to generate for measuring atmospheric pressure in real time
Blood pressure absolute measured value.Controller 44 can include thermometer, calibrated, smart to generate for measuring atmospheric temperature in real time
True blood pressure absolute measured value.
Sensor 24,42a and the 42b of implantation can pass with separated with sensor 24, the 42a and 42b or implantation that implants
The charge storage devices (battery) 46 of sensor module 24,42a and 42b communicate.Charge storage devices 46 can be implant with
Sensor 24, the omniseal battery of 42a and 42b wire communications of implantation.For example, the implantable battery 46 can utilize external power source
Recharged by induction charging via skin.In alternative embodiments, the sensor 24 of implantation, 42a and 42b working power can
Transmitted using electromagnetic coupled or optical coupling via skin and hypodermis from external.Vivo sensing device 24,42a and 42b need to pass
The external power source electricity passed is low, and therefore, transmission range is short.The external power source near skin surface or can be attached to for a long time
Skin surface, the life physical sign monitoring device for implantation are powered or are that the battery being implanted into recharges.
Module 24 containing blood pressure sensor can be by locally or systemically anaesthetizing around thorax (breast) interior artery the (the 3rd and
4th, between the 4th and the 5th or the 5th and the 6th intercostal space) implantation.The artery is perpendicular to rib, positioned at about 1 centimetre on the outside of breastbone
Place, and between internal intercostals and middle intercostal muscle.In an exemplary configuration, module 24 horizontal can be planted in aorta petal
Enter, minimize influence of the position to arterial pressure waveform and blood pressure absolute measured value.In exemplary method for implantation, surgery doctor
Life can pierce through ductus arteriosus wall or wall of vein with small pin, card punch or automatic sewing device.Partly, because pin can be in ductus arteriosus wall
On cause tapered opening, therefore, the Part I 14 of housing 12 can be inserted into the hole formed by pin, so that the first openend 18
General planar, or be partly recessed from basilar memebrane and endothelial cell.In other configurations, pin can pierce through vascular wall completely.Shell
The tube chamber 16 of body 12 can surround pin surrounding and slide, and attach in the hole with ductus arteriosus wall tissue.Afterwards, the hair of module 24
Tubule 28 can be inserted into the tube chamber 16 of housing 12, to attach in housing 12, so that one or more sensor diaphragms 32 can
Substantially with the coplanar setting of opening of first end 18.Support 40 can be surrounded on the outside of artery or vein and set, and be attached to module 24
Side, so as to which housing 12 is fixed in ductus arteriosus wall tissue and vascular wall outside.
In the exemplary configuration (as shown in Figure 3) of module 24, two or more blood pressure sensors can be set around artery
Model transducer, model transducer diaphragm 32 therein are set close to endothelial cell.SpO2 sensors 38 can be outside ductus arteriosus wall
The light source and photodetector of configuration one or more (12 points and 6 orientation) positioned opposite to each other.This alignment configurations can generate
Real-time opto-electronic volume pulsation wave signal with high s/n ratio and minimum movement artifact.Light source and the light detection of SpO2 sensors 38
Device may be additionally located in the ductus arteriosus wall tissue of neighbouring endothelial cell.Outside module 24 (including blood pressure sensor and SpO2 sensors)
Surface, support 40 and additional sensor module 42a and 42b can have metal conduction surface, for example, measurable heart heart real time
Scheme (ECG or EKG) signal and the electrode because of electric signal caused by barrier film and chest wall movement.Module 24 and additional sensor mould
Block 42a and 42b can also include the temperature thermistor of test constantly core temperature and blood heat, and one or more prisons
Survey and record the microphone of heart sound (caardiophonogram), lungs sound, upper respiratory tract sound and gastrointestinal sound.
The vital sign measured by the sensor 42a and 42b of module 24 and/or implantation can be used for warning, diagnose and/or controlling
Treat the disease or symptom associated with the vital sign measured.For example, it can integrate and handle in real time from the sensor of implantation (i.e.
ECG, sphygmomanometer, pulse oximetry, thermometer, microphone, accelerometer and GPS sensor) one or more of in obtain
Measurement data, to provide diagnosis and/or treatment recommendations and/or therapeutic scheme for patient.The trend that the sensor of implantation measures
Data can be measured with atraumatic sensor trend data (body weight that e.g., is measured by title and by camera capture patients head,
The image of neck and trunk) it is integrated, to provide diagnosis and/or treatment recommendations and/or therapeutic scheme for patient.
In an exemplary configuration, the one or more vital signs measured can be obtained by monitoring Non-staying in bed patient
, and controller 44 or remote data base can be shown and/or be stored in, for example, detailed with real-time diagnosis algorithm and patient
The doctor's office and/or central monitoring station of electronic health record (EMR).Afterwards, can be by the vital sign measured and the doctor of patient
Or algorithm is compared based on the predetermined threshold value of vital sign patient's baseline information.For example, user's weight, body can be based on
Height, age, family history, medication, medical history and vital sign data before, are one or more vital signs by algorithm
Measurement data determines a threshold value or scope, and the processor or remote location in controller 44 can be compared to each other to it,
To judge whether to possess medical condition, and whether need by such as phone, short message, the alarm of controller 44, third party's intelligence
Mobile phone or medical condition summing-up mail prompt patient.The algorithm can trigger event, to record important vital sign sensors
Data, and trend data is transmitted to external control module and central monitoring station, for inspection and clinical analysis.Work as vital sign
Sensing algorithm detects that significant change occurs for vital sign trend data, and Non-staying in bed patient can receive acousto-optic hint and police
Report.Symptom, sign, dining situation and medication can be manually entered diagnosis/software for treatment algorithm by patient, so as to enter to disease
Row more safely and efficiently manages.The clinician of Central Monitoring System can be linked up by mobile phone and patient, startup/adjustment medicine
Therapeutic scheme, and summarize the effect treated and obtained over time.Several diagnosis algorithms described below can pass through multimode
Formula monitoring (trend data obtained from more than one vital sign sensors) diagnoses to following symptom：
Myocardial ischemia and miocardial infarction- monitored in real time using ECG, it is relevant with heart rate, blood pressure and activity by analyzing
ST sections force down (horizontal or oblique) or raise, newly send out Q ripples, single source property and polyphyly VPB, atrial premature beats, the supraventricular heart
It is dynamic overrun, auricular fibrillation, new hair conduction delay and the new hair cardiac conduction relevant with myocardial ischemia, miocardial infarction and heart failure
Retardance comes diagnosis of myocardial ischemia and miocardial infarction.In real time monitoring blood pressure waveform be able to detect that blood pressure, heart rate, often win output quantity,
The change of myocardial contractive power, systemic vascular resistance, cardiac output, contraction/relaxation time interval, valvular function and respiratory rate
Change, and this adjoint in rest and motion heart ischemia would generally occur.In real time monitoring heart sound be able to detect that because myocardial ischemia,
Sound of stridulating, bubble, third heart sound and the new bicuspid valve/sustainer that left ventricle (LV) dysfunction and pulmonary edema are triggered
Valve reflux noise.Monitor what may be occurred in detectable rest and motion with myocardial ischemia in real time using pulse blood oxygen instrument
Arterial oxygen saturation drastically declines.Blood pressure waveform is changed into unstable mode from stable mode will be considered as emergency medical situation,
It need to enhance your vigilance, and optimize or take drug therapy in time.
Congestive heart failure and pulmonary edema- can be by monitoring blood pressure waveform in real time to possible with myocardial ischemia, cardiac muscle
Infraction, the myocardial contractive power of cardiomyopathies and heart failure generation, often win output quantity, often win output quantity degree of variation, heart rate, heart rate
The change of degree of variation, contraction/relaxation time interval, valvular function and respiratory rate is detected.The monitoring heart/lungs sound can in real time
Detect sound of stridulating, bubble, third heart sound and the Xin Fa noises because of LV dysfunctions and acute pulmonary edema initiation.Use pulse
The drastically decline of the detectable arterial oxygen saturation of BOLD contrast monitoring in real time.Blood pressure waveform is changed into unstable cover half from stable mode
Formula will be considered as emergency medical situation, need to enhance your vigilance, and optimize or take drug therapy in time.
Hypertension (slight, moderate and severe)- can be (average come office hypertension by monitoring blood pressure waveform pattern in real time
Blood pressure, systolic pressure and diastolic pressure ＞ age brackets desired value) and judge the validity of medical scheme/drug therapy/mechanotherapy.
For example, if systolic pressure, diastolic pressure and mean blood pressure occur continuing ascendant trend and/or continue sychnosphygmia and activity, rest
And sleep is relevant, then can change drug therapy.By real-time blood pressure data and trend data adjustment dosage.ECG monitorings can
Detect acute and chronic effect of the hypertension on left ventricular wall thickness and myocardial electrical activity (left ventricular hypertrophy is with strain).New hair
Moderate/severe hypertension or Blood pressure load, which become unstable, will be considered as emergency medical situation, it is necessary to enhance your vigilance, and optimize
Or drug therapy is taken in time.
Auricular fibrillation or supraventricular tachycardia- ECG in real time monitoring be able to detect that it is spontaneous or secondary to myocardial ischemia,
Congestive heart failure (CHF) or new hair or the recurrent auricular fibrillation of hypertension and/or supraventricular tachycardia.Monitoring in real time
Artery BP waveforms are able to detect that the obvious hydromechanics of arrhythmia cordis changes and (blood pressure, often win output quantity and cardiac output drop
It is low).During arrhythmia cordis using pulse blood oxygen instrument monitoring be able to detect that blood oxygen saturation because CBF declines and it is unstable and
Reduce.New hair auricular fibrillation, supraventricular tachycardia (SVT) or cardiac rhythm pattern become unstable and will be considered as emergency medical shape
Condition is, it is necessary to enhance your vigilance, and optimize or take drug therapy in time.
Acute bronchus spasm (asthma)The change of-vital sign measurements can be used for diagnosis Upper respiratory tract obstruction, big
Respiratory tract obstruction and bronchial spasm (due to asthma or bronchitis) and pneumothorax.Monitoring heart sound, lungs sound and upper breathing in real time
Road sound is able to detect that sound of stridulating, bubble, rhonchus, respiratory rate/tidal volume increase (minute ventilation volume) and exhaled
Time lengthening (breathing acting increase).Monitoring artery BP waveforms are able to detect that heart rate increase, heart rate variability degree increase, are often rich defeated
Output reduces, often wins the reduction of output quantity degree of variation and cardiac output reduction.ECG monitoring be able to detect that heart rate (HR) increase,
HR degrees of variation are reduced, arrhythmia cordis and the acute right impairment of the heart caused by ocerstrain are damaged.Pulse blood oxygen instrument monitoring is able to detect that blood oxygen saturation drastically
Decline.The new adjoint breathing acting of hair bronchial spasm is high and blood oxygen saturation reduction will be considered as emergency medical situation, it is necessary to carry
Height is vigilant, and optimizes or take drug therapy in time.
Chronic obstructive pulmonary disease and respiratory failureThe change of-vital sign measurements can be used for diagnosis by acute branch gas
The deterioration of acute respiratory failure and chronic bronchitis and pulmonary emphysema caused by pipe inflammation or pneumonia.For example, respiratory rate and every
Minute volume increases, coughed, stridulating, blood oxygen saturation reduction, constant tachycardia, myocardial ischemia, the right impairment of the heart caused by ocerstrain damage and body
Temperature rise, which can be shown that, shows now such symptom.Breathing acting Continued and blood oxygen saturation, which reduce, will be considered as emergency medical shape
Condition is, it is necessary to enhance your vigilance, and optimize or take drug therapy in time.
Intestines problem (Crohn disease, ulcerative colitis, diverticulitis and ischaemic)-vital sign measurements
Change can be used for the decompensation of diagnosis IBD.For example, gurgling sound (activity) increases/lowered, body temperature raises, heartbeat mistake
Speed, low blood pressure, CBF are reduced, being short of breath to reduce with blood oxygen saturation shows such symptom occur.
Pulmonary embolismThe change of-vital sign measurements can be used for Diagnosis of Pulmonary Embolism.For example, anxious hair property stridulates, breathes frequency
Rate increase, minute ventilation increase, sychnosphygmia, room/ventricular arrhythmia, EKG show right impairment of the heart caused by ocerstrain damage pattern, blood oxygen saturation
Reduce, body temperature raises, often win output quantity attenuating, cardiac output reduces and low blood pressure can be shown that such symptom occur.Any lung
Embolism all will be considered as emergency medical situation, it is necessary to enhance your vigilance, and optimize or take drug therapy in time.
Bleeding or dehydrationThe change of-vital sign measurements can be used for diagnosis because bleeding, oedema, oral consumption reduce,
Urination is excessive or diarrhoea caused by obvious dewatering symptom.For example, heart rate, peripheral vascular resistance, respiratory rate and minute ventilation
Increase and often win the attenuating of output quantity, cardiac output, blood pressure, CBF and blood oxygen saturation and can be shown that moderate occur to severe
Lose blood and/or be dehydrated.
Above-mentioned symptom is only the vital sign determined by sensor assembly 24 and/or other sensors module 42a and 42b
Measurement data multiple use example, these vital signs can be measured and for related to the given threshold of patient in real time
Connection, so as to send alarm signal, or record data to user or health care professional's (primary care physician or central monitoring station),
For further being assessed.For example, as it is known that patient of the blood pressure thresholds of the patient with auricular fibrillation with being not suffering from auricular fibrillation
It is different.Therefore, the threshold value can be programmed into controller 44 by doctor or by remote data base automated programming, so as to be moved in real time
When threshold value in equipment is above or below the threshold value, warning is sent to patient, central monitoring station and/or patient doctor.Similarly,
For there is the patient of other symptoms, its each vital sign measurements measured by module 24 and/or 42a and 42b is respectively provided with
Different threshold value, so as to which when each module 24 is used in combination with controller 44, every patient can be directed to before ill-effect generation
Each symptom personalized early stage warning is provided.Simple threshold values, prediction threshold value or patient physiological's model can be based on and send police
Report and warning.In addition, vital sign measurements can be also based on, by treating the R. concomitans of algorithm and diagnosis algorithm, according to
The vital sign measurements of acquisition compared with each with patient threshold value or scope, it is proposed that treatment patients and/or for patient implement
Treatment.For example, treatment algorithm can be run in the following manner in above-mentioned symptom：
Myocardial ischemia- although to have more than 80% myocardial ischemia be asymptomatic, and many " chest pains " and by
Caused by non-cardiac reason, still, at present, doctor and patient are tackled " pectoralgia " (angina pectoris) by titration of medicines dosage
Etc. symptom.Ischemic heart disease medicine can be administered once a day or repeatedly based on the vital sign data of quantization.Real time data
Available for according to patient medical history and vital sign historical measurement data " it is recommended that " (nitrate, ACE suppress adjustment therapeutic scheme
Agent, beta-blocker, calcium channel blocker, aspirin, anticoagulant and oxygen).It is it is further envisioned that raw in real time
Life condition sensor system and closed loop therapies algorithm can utilize medication infusion pump and/or utilize oxygen by oxygen source and oxygen pressure regulator
The anti-ischemic medicine of gas automatic transport.Real time data can also be used to automatically adjust nerve fiber electrical stimulation apparatus and cardiovascular blood
Pump installation, optimize blood pressure and blood pressure flow in diseased heart.
Congestive heart failure and pulmonary edema- as described above, the change of vital sign patient's pattern can be used for detection congested
The early onset thereof of DHF (CHF) and pulmonary edema, so that mobile device can be implemented to manage, patient is avoided to enter emergency treatment
Room and intensive care unit receive treatment.Vital signs in real time sensing data can be used for being directed to drug therapy (diuretics, catechol
Amine, digitalis, nitrate, beta-blocker, calcium channel blocker, Vel-Tyr-Pro-Trp-Thr-Gln-Arg-Phe and oxygen) in occur acute change carry
For suggesting.It is further envisioned that vital signs in real time sensing system and closed loop therapies algorithm can utilize medication infusion pump
Treat with electrical stimulation apparatus automatic transport medicine, oxygen, pacing therapy, ventricular assist device, and myocardial contractive power can be increased,
Control heart rate, blood pressure, CBF and oxygen concentration and reduce the TAH treatment of systemic vascular resistance.
Hypertension-by the real-time analysis to blood pressure waveform can calculate heart rate, the rhythm of the heart, often win output quantity, artery blood flow
Amount, myocardial contractive power and systemic vascular resistance.Vital sign sensors data can be used for for drug therapy (diuretics, β by
Body retarding agent, α ARBs, vasodilator, Vel-Tyr-Pro-Trp-Thr-Gln-Arg-Phe and calcium channel blocker) in occur acute change provide
It is recommended that and monitor the validity of the drug therapy.It is further envisioned that vital signs in real time sensing system and closed loop are controlled
Medication infusion pump and nerve fiber electrotherapy can be utilized come automatic transport drug for hypertension by treating algorithm, make patient rest, move,
Sleep is maintained in target range with mean blood pressure, systolic pressure and diastolic pressure during one's sickness.
Arrhythmia cordis- vital signs in real time sensing data can be used for being directed to drug therapy (beta-blocker, calcium channel
Retarding agent and membrane stabilizer) in occur acute change provide suggestion.It is further envisioned that vital signs in real time sensor
System and closed loop therapies algorithm can utilize medication infusion pump automatic transport antiarrhythmic drug, and utilize electric defibrillation, electric shock
Conversion and/or the electric shock of override control pace-making carry out anti-arrhythmia peb treatment.
Asthma- vital signs in real time sensing data can be used for providing acute drug treatment recommendations (oxygen, catecholamine
Inhalant, steroid inhalants and parenteral catecholamine).It is further envisioned that vital signs in real time sensing system
Medication infusion pump can be utilized with closed loop therapies algorithm, oxygen is utilized by oxygen source/oxygen pressure regulator and utilizes nerve fiber electricity
Automatic transport anti-inflammatory and anti-bronchiectasis medicine are stimulated, to reduce bronchial spasm and inflammation.
Chronic obstructive pulmonary disease (COPD)- vital signs in real time sensing data can be used for for drug therapy (oxygen,
Catecholamine inhalant, steroid inhalants and parenteral catecholamine) in acute change provide suggestion.It is further envisioned that
, vital signs in real time sensing system and closed loop therapies algorithm can utilize medication infusion pump, pass through oxygen source/oxygen pressure regulator
Using oxygen and nerve fiber electro photoluminescence automatic transport anti-inflammatory and anti-bronchiectasis medicine are utilized, to reduce bronchial spasm
And inflammation.
Chronic intestinal disease- vital signs in real time sensing data can be used for for drug therapy (venous transfusion, oxygen,
Steroids and antiphlogistic) in acute change provide suggestion.It is further envisioned that vital signs in real time sensing system and
Closed loop therapies algorithm can utilize medication infusion pump automatic transport antiphlogistic with promoting wriggling and antiperistaltic.
The vital sign data measured can be further processed, to determine vital sign trend data relative to common strong
Health patient/stabilization patient is with the presence or absence of "abnormal" or reaches " limit ", or whether is applied to individual patient.For example, all or
Any one sensor is recordable and analyzes the vital sign data in patient's hundreds of to thousands of hours.Large data sets can be divided into
(1) training set, (2) domination set and (3) test set.Clinical expert can check trend data, and AD HOC is labeled as into " crisis
Event " or " error code ".Algorithm can be from the physiological patterns learning of individual patient, and high sensitivity and determines with high specificity
When "abnormal" be present or reach " limit " in (minimum false alarm shows/false alarm and seldom fail to report " true " event) trend data.Should
Real-time method can estimate the Multivariate Extreme Value Distribution and multimode of the complex data collection for analyzing physiological vital condition sensor array
State mixed model.
In one embodiment of the invention, the present invention includes vital signs in real time monitoring system.The vital signs in real time
Monitoring system includes implantable sensor module.The implantable sensor module is configured to be maintained at the vascular wall of Non-staying in bed patient
It is interior；At least one vital sign of measurement patient in real time；And with controller radio communication.The controller is configured to compare and measured
At least one vital sign vital sign baseline threshold corresponding with patient, and deviate at least one vital sign for measuring
When one predetermined value of vital sign baseline threshold of patient, generation warning.
In the another aspect of the present embodiment, controller is smart mobile phone, and including display screen, wherein, generation warning includes
The medical of medical conditions that display causes generation to warn is made a summary.
In the another aspect of the present embodiment, controller is further configured to deviate from least one vital sign measured
During one predetermined value of vital sign baseline threshold of patient, at least one vital sign measured is transmitted to remote sensing station.
In the another aspect of the present embodiment, the vital sign baseline threshold of patient is at least partially based on individual patient predetermined
The vital sign measured in period.
In the another aspect of the present embodiment, the vital sign baseline threshold of patient can not update with the time.
In the another aspect of the present embodiment, at least one vital sign includes multiple vital signs.
In the another aspect of the present embodiment, processor be further configured to based on the multiple vital signs measured with it is corresponding
Comparison between vital sign patient's baseline threshold determines one or more medical conditions.
In the another aspect of the present embodiment, wherein, at least one vital sign includes blood pressure.
In the another aspect of the present embodiment, at least one vital sign includes cardiac rhythm.
In the another aspect of the present embodiment, at least one vital sign includes blood oxygen concentration.
In the another aspect of the present embodiment, implantable sensor module includes at least one and doctor of one or more determinations
The corresponding therapeutic agent of symptom is treated, and wherein, processor is further configured to deviate from trouble in the multiple vital signs measured
Corresponding to person during one predetermined value of vital sign baseline threshold, discharge at least one therapeutic agent.
In another embodiment of the present invention, the present invention includes implanted vital sign sensors.The implanted life
Condition sensor includes implantable sensor module.The implantable sensor module is configured to be maintained at the blood vessel of Non-staying in bed patient
In wall；The measurement at least one vital sign of patient in real time；Receive the instruction that patient's remote controllers are sent；And release at least one
Kind therapeutic agent.
It will be understood to those of skill in the art that the invention is not limited in the content having had been particularly shown and described above.This
Outside, it should be noted that unless above there is opposite explanation, all accompanying drawings are non-drawn to scale.According to above-mentioned teaching, do not departing from
On the premise of scope and spirit of the present invention, various modifications and variations can be done to the present invention, and the present invention only will by appended right
The limitation asked.
Claims (15)
1. a kind of implanted vital sign measurement device for being used for patient vessel by vascular wall, including：
Housing, the housing include Part I, and first openend of Part I restriction, relative with first end second open
Mouth end and the tube chamber passed through, the size of the Part I substantially all can be implanted into patient vessel's wall；And
Sensor assembly, it is configured to measure artery blood pressure waveform, the sensor assembly has portions of proximal and distal part,
The distal part is inserted into the tube chamber, and the portions of proximal stretches out from first openend.
2. device according to claim 1, wherein, the sensor assembly includes pressure sensor, the pressure sensing
Utensil has the diaphragm located at distal part, and when the distal part insertion tube intracavitary, the diaphragm and the housing
Second openend is approximately coplanar.
3. device according to claim 1, wherein, the housing further comprises what is be substantially orthogonal with the Part I
Part II；When in the Part I implantation ductus arteriosus wall of the sensor assembly, the size of the Part II can be complete
It is placed in entirely on the outer surface of the ductus arteriosus wall.
4. device according to claim 3, wherein, when the distal part insertion tube intracavitary of the sensor assembly, institute
The portions of proximal for stating sensor assembly is configured to be pressed against the Part II of the housing.
5. device according to claim 1, wherein, at least a portion in the portions of proximal is configured to seal described
One openend, and in the distal part insertion tube intracavitary of the sensor assembly, there is provided predetermined insertion depth.
6. device according to claim 1, wherein, the Part I of the housing is generally cylindrical, and wherein institute
The length of Part I is stated between 100-1500 microns.
7. device according to claim 6, wherein, the length of the Part I in the thorax (breast) of patient substantially with moving
In the long artery of arteries and veins, chest, sustainer, arteria carotis, arteria brachialis, ulnar artery, radial artery, the arteria renalis, Pi arteries, common iliac artery and femoral artery
At least one or vena mammaria interna, jugular vein, vena cave, renal vein, splenic vein, one in iliac vein and femoral vein
Thickness is equal.
8. device according to claim 1, further comprise the sensor assembly holding element for being connected to sensor assembly,
The sensor assembly holding element is configured to the sensor assembly being maintained in the Part I.
9. device according to claim 8, wherein, the sensor assembly holding element includes the chain of multiple interval connections
Ring, when the distal part is inserted in the Part I, the chain link configures generally about blood vessel surrounding.
10. device according to claim 9, wherein, the portions of proximal of the sensor assembly have the first side and with institute
The second relative side of the first side is stated, and the sensor assembly holding element has first end and the second end, and it is wherein described
The first end of sensor assembly holding element is fixed to the first side of the sensor assembly, and the sensor assembly keeps member
Second side of part is fixed to the second end.
11. device according to claim 9, further comprise at least one blood oxygen saturation (SpO2) sensor, it is described
SpO2 pulse oximetry sensors have photo-detector, and at least one in multiple interval joining links therein
Including aperture, and wherein described photo-detector is configured to be maintained in the aperture, and towards the vascular wall.
12. device according to claim 1, wherein, the sensor assembly is removably inserted into the Part I.
13. device according to claim 1, wherein, the sensor assembly is electrically communicated with charge storage cell, and
Wherein described charge storage cell passes through patient skin induction charging.
14. device according to claim 1, wherein, the sensor assembly is configured to measure Non-staying in bed patient in real time
Pressure value.
15. a kind of implanted vital sign measurement device for being used for patient's artery by ductus arteriosus wall, the ductus arteriosus wall have
Basilar memebrane, described device include：
Elongated and biodegradable housing, the housing, including：
Part I, the Part I limit the first openend, second openend relative with first end and passed through
Tube chamber, the size of the Part I can be substantially fully implanted in patient vessel's wall；And
Part II, it is substantially orthogonal with the Part I, and when the distal end insertion ductus arteriosus wall of the Part I and its
When basilar memebrane and the substantially coplanar position of endothelial cell, it is configured to contour with the outer surface of the ductus arteriosus wall；And
Sensor assembly, it can be maintained in the Part I, the sensor assembly has pressure sensor, is configured to
Arterial blood pressure waveform is measured, the sensor assembly has the suitable diaphragm of response intra-arterial blood pressure waveform, when the sensor
When module is maintained in the Part I, the basilar memebrane and endothelial cell of the diaphragm and ductus arteriosus wall are substantially coplanar.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
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| US201562143592P | 2015-04-06 | 2015-04-06 | |
| US62/143,592 | 2015-04-06 | ||
| US201562168754P | 2015-05-30 | 2015-05-30 | |
| US62/168,754 | 2015-05-30 | ||
| PCT/US2016/024655 WO2016164199A1 (en) | 2015-04-06 | 2016-03-29 | Implantable vital sign sensor |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN107708527A true CN107708527A (en) | 2018-02-16 |
Family
ID=55661657
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201680032864.9A Pending CN107708527A (en) | 2015-04-06 | 2016-03-29 | Implanted vital sign sensors |
Country Status (4)
| Country | Link |
|---|---|
| US (5) | US9629560B2 (en) |
| EP (1) | EP3280315B1 (en) |
| CN (1) | CN107708527A (en) |
| WO (1) | WO2016164199A1 (en) |
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Also Published As
| Publication number | Publication date |
|---|---|
| US10602936B2 (en) | 2020-03-31 |
| US20190350468A1 (en) | 2019-11-21 |
| US10413200B2 (en) | 2019-09-17 |
| EP3280315B1 (en) | 2020-11-18 |
| US20170360312A1 (en) | 2017-12-21 |
| US20160287174A1 (en) | 2016-10-06 |
| WO2016164199A1 (en) | 2016-10-13 |
| US11445924B2 (en) | 2022-09-20 |
| US20190313923A1 (en) | 2019-10-17 |
| US9629560B2 (en) | 2017-04-25 |
| EP3280315A1 (en) | 2018-02-14 |
| US20160287094A1 (en) | 2016-10-06 |
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